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A Comparison of Midazolam and Zolpidem as Oral Premedication in Children (PedsPreMed)

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ClinicalTrials.gov Identifier: NCT02096900
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : August 11, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Davinder Ramsingh, MD, Loma Linda University

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 26, 2014
Results First Submitted Date  ICMJE April 19, 2017
Results First Posted Date  ICMJE August 11, 2017
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE July 21, 2014
Actual Primary Completion Date May 6, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
Patient Anxiety at the Time of Separation [ Time Frame: Up to 24 hours including preoperative, preoperative, and postoperative periods. ]
The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures. The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
Medication effectiveness [ Time Frame: Study participation will be about 1 day including the preoperative, perioperative at the time of induction, and postoperative period ]
The primary outcome measure will be 2 questionaires that will be filled out by the parent or legal guardian.
Change History Complete list of historical versions of study NCT02096900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • Mask Acceptance Score [ Time Frame: During induction of general anesthesia. ]
    Mask acceptance by the patient, will be measured on a 4-point scale adapted from a similar trial. Score of 1 and 2 indicates satisfactory mask acceptance. Score of 3 or 4 indicates unsatisfactory mask acceptance during induction of general anesthesia.
  • Presence of Emergence Delirium During Recovery [ Time Frame: Up to 30 minutes after child's first eye opening in the post-operative period. ]
    Presence or absence of emergence delirium during recovery, will be assessed using the pediatric anesthesia emergence delirium (PAED) scale recorded at 5-minute intervals for 20 minutes following the child's spontaneous eye opening. PAED score of ≥12 at any time indicates presence of emergence delirium.
  • Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI) [ Time Frame: Preoperative holding area from the time of informed consent until caregiver/patient separation. ]
    Parental/caregiver anxiety, was assessed using the validated State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. The STAI is compromised of separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment". The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how respondents generally feel. The score ranges from 20 (most relaxed) to 80 (highest stress). The baseline STAI inventory was completed by e parent/caregiver after obtaining the informed consent in the preoperative holding area and before the subject was separated from the caregiver. Baseline STAI inventory consisted of form STAIY-1 (State Anxiety) and form STAIY-2 (Trait Anxiety) anxiety. After caregiver/patient separation,form STAIY-1(State Anxiety) was completed again by the caregiver.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
Patient anxiety at the time of separation from parent/caregiver [ Time Frame: The secondary outcome measure will begin at the time the subject is taken to the operating room and will continue for 20 minutes after the child's spontaneous eye opening. ]
All ratings will be performed by a member of the research team familiar with the scoring system
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Official Title  ICMJE A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Brief Summary The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parental/Caregiver Anxiety
  • Child's Anxiety
Intervention  ICMJE
  • Drug: zolpidem
    Zolpidem will be given one time at 0.25 mg/kg pre-operatively
    Other Name: ambien
  • Drug: Midazolam
    Other Name: versed
Study Arms  ICMJE
  • Active Comparator: zolpidem
    zolpidem given orally 0.25mg/kg pre-operatively single dose
    Intervention: Drug: zolpidem
  • Active Comparator: midazolam
    midazolam will be given at 0.5mg/kg, pre-operatively single dose
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2016)
86
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)
80
Actual Study Completion Date  ICMJE May 6, 2016
Actual Primary Completion Date May 6, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pediatric patients ages 2-9 years
  • ASA class I-II
  • inpatient surgeries of at least 2 hours duration
  • requiring postoperative admission of at least 23 hours Exclusion Criteria:

Exclusion Criteria:

  • contraindication to preoperative sedation, known allergy or sensitivity to the study medications,
  • those who lack legal representative consent
  • Patients with weights lying below the 5th percentile or above the 95th percentile according to the current published CDC growth chart will also be excluded regardless of existing specific contraindication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02096900
Other Study ID Numbers  ICMJE 5140032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Davinder Ramsingh, MD, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amgad Hanna, MD Loma Linda University
PRS Account Loma Linda University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP